Endoscopic suture system

ABSTRACT

A method and device for the placement of sutures and for the purpose of approximating tissue. A particular utility is effected in the approximation of the tissue separated by means of an endosurgical trocar being inserted into a body cavity. The invention provides for the loading of suture material including needles into the device, introduction and placement of the device into the body cavity, with the distal end having deployable needle guides, extending the needle guides either simultaneously or individually to the periphery of the wound, engaging the wound with the needle guides, driving the needles and suture material through the tissue to be approximated into a catch mechanism, retracting the needle guides and withdrawing the device, leaving a loop of suture material in the margin of tissue. The suture may then be tied to approximate the wound and excess suture material cut off.

RELATED APPLICATION

This patent application is a Division of application Ser. No.08/057,699; filed on May 4, 1993, by inventors Norman S. Gordon, RobertP. Cooper & Richard L. Quick and entitled "Endoscopic Suture System",now U.S. Pat. No. 5,458,609, which is a continuation-in-part of parentpatent application Ser. No. 07/941,382, filed Sep. 4, 1992, by inventorNorman S. Gordon, and entitled "Endoscopic Suture System" now U.S. Pat.No. 5,364,408.

FIELD OF THE INVENTION

The invention relates to devices for approximation of tissue using asuture, and particularly to the tissue separated by means of anendosurgical trocar being inserted into a body cavity.

BACKGROUND OF THE INVENTION

Suturing of body tissues is a time consuming aspect of most surgicalprocedures. Many surgical procedures are currently being performed whereit is necessary to make a large opening to expose the area of, forinstance, the human body that requires surgical repair. There areinstruments that are becoming increasingly available that allow theviewing of certain areas of the body through a small puncture woundwithout exposing the entire body cavity. These viewing instruments,called endoscopes, can be used in conjunction with specialized surgicalinstrumentation to detect, diagnose, and repair areas of the body thatwere previously only able to be repaired using traditional "open"surgery.

In the past, there have been many attempts to simplify the surgeons'task of driving a needle carrying suture through body tissues toapproximate them. Many prior disclosures, such as described in Drake etal, U.S. Pat. No. 919,138 issued Apr. 20, 1909, employ a hollow needledriven through the tissue with the suture material passing through thehollow center lumen. The needle is withdrawn leaving the suture materialin place, and the suture is tied, completing the approximation. Alimitation of these type of devices is that they are particularlyadapted for use in open surgical procedures where there is room for thesurgeon to manipulate the instrument.

Others have attempted to devise suturing instruments that resembletraditional forceps, such as Bassett, U.S. Pat. No. 3,946,740 issuedMar. 30, 1976. These devices pinch tissue between opposing jaws and passa needle from one jaw through the tissue to the other jaw, wheregrasping means pull the needle and suture material through the tissue. Alimitation of these designs is that they also are adapted primarily foropen surgery, in that they require exposure of the tissues to besutured. This is a severe limitation in the case of endoscopic surgery.

The term "endosurgery" means endoscopic surgery or surgery performedusing an endoscope. In conjunction with a video monitor, the endoscopebecomes the surgeons' new eyes from which they operate. Operations usingan endoscope are significantly less invasive when compared totraditional open surgery. Patients usually return home the next day orin some cases the same day of the endosurgical procedure. This is incontrast to standard open surgical procedures where a large incisiondivides the muscle layers and allows the surgeon to directly visualizethe operative area. Patients may stay in the hospital for 5 to 6 days orlonger following open surgery. In addition, after endosurgicalprocedures, patients return to work within a few days versus thetraditional 3 to 4 weeks at home following open surgery.

Access to the operative site using endosurgical or minimally invasivetechniques is accomplished by inserting small tubes called trocars intoa body cavity. These tubes have a diameter of, for example, between 3 mmand 30 mm and a length of about 150 mm (6 inches). There have beenattempts to devise instruments and methods for suturing within a bodycavity through these trocar tubes. Such an instrument is disclosed byMulhollan et al, U.S. Pat. No. 4,621,640 issued Nov. 11, 1986. Mulhollandescribes an instrument that may be used to hold and drive a needle, butmakes no provision for retrieval of the needle from the body cavity, northe completion of the suture by tying. Another such instrument isdescribed by Yoon, U.S. Pat. No. 4,935,027, issued Jun. 19, 1990. Thisinstrument uses oppositional hollow needles or tracks pushed through thetissue and coapted to create a tract through which the suture materialis pushed. It is not clear how these curved tracks would be adapted toboth be able to pierce the tissue and be curved toward each other toform the hollow tract.

The invention herein described may be used for final closure ofumbilical and secondary trocar puncture wounds in abdominal tissuesincluding the fascia and other layers. The umbilical puncture isroutinely a puncture site of 10 mm to 12 mm. Future procedures mayrequire trocar puncture sites up to 18 mm and greater in size. Due tothe large size of the puncture wound, it is important that the site beclosed or approximated at the interior abdominal wall following removalof the large trocar cannula. An improper or non existent closure canlead to a herniation of the bowel and/or bowel obstruction. The presentmode for closure is to reach down to the desired tissue layer with apair of needle drivers holding a needle and suture material and secure astitch. Many patients are obese and present considerable fat in thisregion. Because the abdominal wall may be several inches thick, it isextremely difficult, tedious and time consuming to approximate thefascial tissues with a suture. Often times, following removal of a largetrocar, the puncture site needs to be enlarged to accomplish this, thusnegating some of the advantages of endoscopic surgery previouslydiscussed.

It is well known in the art that the use of particular suture materialsfor specific applications is desirable. In the case of closure ofabdominal wall defects caused by operative wounds, trauma, orspontaneous separation, e.g. hernias, it is generally desirable to usean absorbable suture material. Such sutures may be made from syntheticmaterials such as polyglycolic acid, designed to be absorbed into thebody by means of hydrolysis. As a result, these materials requirespecialized packaging and sterilization methods, known in the art as"bone dry" packaging. Such packaging processes are described by Glick inU.S. Pat. No. 4,135,622 issued Jan. 23, 1979 and assigned to AmericanCyanimid Corporation. Essentially, because of the sensitivity of thesematerials to degradation of tensile strength in the presence ofmoisture, they need to be sterilized and packaged in an environment thatguarantees that they remain bone dry.

Due to these packaging constraints, it is desirable that the suturematerial along with the needles be packaged separately from the sutureapplicator. As a result, it is desirable to have a loading system thatallows the user to quickly and easily place the needles and suturematerial into the applicator and prepare the applicator for use in thebody. It will be clear to those skilled in the art that this loadingsystem would be adaptable to include any of the available suturematerials, such as silk, polyester, polypropylene, catgut and the like,even though these materials may not require the specialized packagingthat the synthetic absorbable materials do.

None of the prior art devices are adaptable to effect the placement of asuture in the anterior abdominal wall. It is therefore an object of thepresent invention to provide a novel suturing device that overcomes theabove set out disadvantages of prior known devices in a simple andeconomical manner.

It is a further object of the present invention to provide a suturedevice that will permit the approximation of the separated edges of apuncture wound without making a larger incision to expose the woundmargins.

A further object of the present invention is to provide a suture devicethat will permit the surgeon to apply substantial force to the needle,permitting it to be driven through tough tissues, for example, theabdominal fascia.

It is a further object of the present invention to provide a suturedevice that can be used in conjunction with modern day endoscopicsurgical techniques.

Yet another object of the invention is to provide a suture device thatmay be used to approximate the edges of an internal wound. Anotherobject of the present invention to provide a suture device that permitsthe penetration of two needles having suture material extending therebetween into and through the sides of a wound and into catches therebycreating a suture loop through the wound that may be tied to approximatethe tissues.

A further object of the present invention is to provide a loading systemfor suture material that allows the user to quickly and easily preparethe device for use.

Yet another object of the present invention is to provide a suturestorage system which is compatible with current sterilization processesand incorporates the functionality of the above suture loading system.

SUMMARY OF THE INVENTION

The present invention is a new medical device that will allow thesurgeon to quickly and easily place a suture in the interior wall of abody cavity to approximate the tissues separated as a result of apuncture wound made by the introduction of a surgical trocar into a bodycavity during endoscopic surgery. The invention described herein mayalso be used to approximate the margins of an open wound in an internalorgan, such as the uterus or the stomach, such as would be effectedduring the course of a resection for benign or malignant lesions. Thismay be done by adapting the device to allow for the needles to beactuated and driven independently.

The present invention includes needle holders that releasably hold apair of needles that are in turn attached to each end of a single pieceof suture material. Such needle holders are held within tubular guidingtracks housed within a hollow outer sleeve that may be introduced into apuncture wound. The needle holders and guiding tracks may be deployedoutside the hollow sleeve to allow the needles to engage the tissue tobe approximated. A plunger is coupled to rigid driving members that arein turn attached to flexible driving members adapted to follow the shapeof the guiding tracks. The flexible driving members are suitablyattached to the needle holders. The plunger is pushed, simultaneouslydriving the needle pair into opposite sides of the puncture wound andinto catches also disposed within the hollow sleeve. The needle holdersare retracted into the guiding tracks, and the tracks pulled back intothe hollow sleeve trailing the suture material. The device may then bewithdrawn, leaving a loop of suture material precisely placed in theselected tissue, for example, in the interior wall of the body cavity.The needles are removed from the ends of the suture, and the suturematerial is tied to complete the approximation of the tissue.

In one aspect, the present invention differs from the prior art in thatit allows a suture to be placed in a retrograde fashion in the puncturewounds created during the introduction of trocars used for endoscopicsurgery. These puncture wounds have margins perpendicular to the planeof tissue dissection, unlike the wounds that are addressed by prior artin which the tissues generally overlap. Presently all the existinginstruments are designed to either approximate tissues to which directvisual and physical access may be gained during open surgery, or toapproximate tissues that may be pinched between the jaws of a forcepslike instrument. Wounds in body organs such as the uterus or the stomachwhich are created during the resection or removal of benign or malignantlesions may also have wound margins which require end to endapproximation instead of overlapping. The present invention allows thesurgeon to independently pass a needle through each side of the wound toallow the two sides to be drawn together, approximating the tissue.

The needle driver apparatus of the present invention may be constructedin a number of different ways. Several of the preferred ways aredescribed herein. One embodiment uses needle guides which aresemicircular in shape, holding either a semicircular needle, or asemicircular needle holder with a small needle tip. These guides aredisposed across their diameter within a hollow tubular sleeve when inthe retracted mode, and are rotated about one end to deploy them outsidethe bounds of the hollow sleeve for engaging the tissue to be sutured.The needles, or the needle holders, are driven through the tissue byaxial movement of a rigid cylindrical member which contacts a flexiblecylindrical member that follows the semicircular shape of the guidetracks. The needles are caught in catches placed within the hollowtubular sleeve that capture the needle by means of a leaf springdisposed to flex, preferably in one direction, and squeezing intogrooves or recesses in the needles, thereby retaining the needles to thehollow tubular sleeve. The needle guides may be retracted, and theinstrument removed from the wound, thus trailing the suture material.The needles are removed, the suture is tied, and the approximation iscompleted.

Another version of the device uses similar semicircular needle holdersto the previous version, but the needle guides are eliminated. Theneedle holders are instead rotated about their axes such that theneedles attached to the ends of the holders describe an arc thatencompasses the tissue to be sutured.

Yet another embodiment of the device uses elongated guides with hookedends, the ends describing semicircles, housed within a hollow tubularmember. Into the hooked ends are placed needles with the suture materialbetween. The needle guides are translated axially and then radially todispose them outside the bounds of the hollow tubular member. Thecatches are attached directly to the needle guides, to allow for theirprecise placement relative to the needle path.

It is contemplated that the above embodiments may be modified to includeneedle paths other than circular, such as elliptical or straight, bymodification of the needles, the needle holders and the needle guides.It is also possible to utilize a tool that would use only a singleneedle and guide it through both sides of the wound as opposed to thedouble needle configuration described above. It is also possible toadapt the above configurations to allow each of the needles to beactuated and driven independently by dividing the deployment controlsand the needle drivers into separate left and right hand members.

In one embodiment, the present invention comprises a surgical suturedevice for applying a suture to approximate tissue surrounding a trocarpuncture wound in a body cavity wall. The suture device comprises afirst needle and a second needle attached to opposite ends of a lengthof suture material; a needle catch; a needle deployment mechanism formoving the first and second needles along first and second paths whichterminate in the needle catch; and a cannular body member for insertingthe first needle, the second needle, the suture material, the needlecatch and the needle deployment mechanism into a body cavity through apuncture wound in a wall of the body cavity. The needle deploymentmechanism transports the needles to regions outside of the cannular bodymember, into the body cavity wall and back into the cannular bodymember, thereby forming a loop of the suture which approximates tissueon opposing sides of the puncture wound when the cannular body member,along with the first needle, the second needle, the suture material, theneedle catch and the needle deployment mechanism are extracted from thebody cavity. This device may further include first and second needleguides for directing the first and second needles and/or first andsecond needle carriers for holding the first and second needles. Forsome applications, the needle carriers and needle guides have asubstantially semi-circular shape. The device may further include afirst flexible cylindrical member for pushing the first needle throughthe first needle guide.

Another embodiment of the invention is in the form of a suture devicehaving a first needle having a suture attachment point; a second needlehaving a suture attachment point; a suture having a first end attachedto the first needle suture attachment point and a second end attached tothe second needle suture attachment point; a capture system forreceiving and retaining the first and second needles; a needledeployment system for: a) moving the first needle along a first pathwhich initially diverges away from the capture system and subsequentlyconverges toward the capture system; and b) moving the second needlealong a second path which initially diverges away from the capturesystem and subsequently converges toward the capture system; and acannular body member having a chamber for containing the first andsecond needles; the suture; the needle deployment system; and thecapture system.

In yet another embodiment, the invention describes a suture devicecomprising: a first needle and a second needle attached to opposite endsof a length of suture material contained within a tubular body member;and a needle deployment mechanism contained within the tubular bodymember for moving the first and second needles along first and secondpaths which traverse regions external to the body member and return to acatch mechanism on the body member. Additionally, first and secondneedle guides may be included which define the shape of the first andsecond paths traversed by the first and second needles.

An additional embodiment includes a suture application apparatuscomprising: a needle attached to a suture; and a needle deploymentmechanism which transports the needle along a path which firstintercepts one side of a plane of reference, passes through the plane,reverses direction and then intercepts the opposite side of the plane.

The invention encompasses a method of approximating a trocar puncturewound in the wall of a body cavity. The method includes the followingsteps: 1) inserting a cannular body member having a chamber into thebody cavity through the puncture wound, wherein the chamber contains afirst needle and a second needle attached to opposite ends of a lengthof suture material, a needle catch device and a needle deploymentmechanism; 2) extending the first needle into a first region of the wallof the body cavity adjacent the puncture wound and the second needleinto a second region of the wall of the body cavity adjacent thepuncture wound with the needle deployment mechanism; 3) capturing thefirst and second needles in the needle catch device; and 4) extractingthe body member from the body cavity through the puncture wound, therebyforming a loop of the suture which is secured to opposing regions of thepuncture wound.

The invention also incorporates a method of approximating a wound in abody organ within a body cavity. The method includes the followingsteps: 1) inserting a cannular body member having a chamber into thebody cavity through a puncture wound, wherein the chamber contains afirst needle and a second needle attached to opposite ends of a lengthof suture material, a needle catch device and a needle deploymentmechanism; 2) extending the first needle into a first region of thewound of the body organ; 3) driving and capturing said first needle inthe needle catch device; 4) extending the second needle into a secondregion of the wound of the body organ; 5) driving and capturing saidsecond needle in the needle catch device; and 6) extracting the bodymember from the body cavity through the puncture wound, thereby forminga loop of the suture which is secured to opposing regions of the woundin the body organ.

In one embodiment, the present invention is for a suture devicecomprising: an elongate cannular body member which defines an internalchamber; a first actuator located near a proximal end of the cannularbody member and extending into the internal chamber, the first actuatorhaving a retracted position and a deployed position; and a first needledeployment mechanism comprising a needle carrier pivotally mountedwithin the internal chamber near a distal end of the elongate cannularbody member, the first needle deployment mechanism connected to thefirst actuator and having a retracted configuration when the firstactuator is in the retracted position wherein substantially all of thefirst needle deployment mechanism is contained within the internalchamber and a deployed configuration when the first actuator is in thedeployed position wherein the first needle deployment mechanismtransports the needle carrier outside of the internal chamber along apath having an initial direction away from the cannular body member asthe first actuator begins to move from the retracted position toward thedeployed position followed by a direction toward the cannular bodymember as the first actuator approaches the deployed position. Thisembodiment may further comprise a needle having a suture attachmentpoint inserted in the needle carrier; a suture attached to the needlesuture attachment point; and a needle capture system located on thecannular body member at a location which intercepts the portion of theneedle carrier path which approaches toward the cannular body member.Alternatively, this embodiment may further comprise a second actuatorand a second needle deployment mechanism which are deployableindependently of the first actuator and the first needle deploymentmechanism. A second alternative embodiment further comprises a secondneedle deployment mechanism which is deployable simultaneously with thefirst needle deployment mechanism by the first actuator, wherein thefirst and second needle deployment mechanisms are deployed on oppositesides of the cannular body member. In yet a third alternativeembodiment, the suture device first actuator comprises a firstsub-actuator and a second sub-actuator, each having a retracted positionand a deployed position which is independent of the other, wherein thefirst needle deployment mechanism transports the needle carrier outsideof the internal chamber along the path having an initial direction awayfrom the cannular body member as the first sub-actuator moves from theretracted position toward the deployed position followed by thedirection toward the cannular body member as the second sub-actuatormoves from the retracted position toward the deployed position.

The invention also encompasses a suturing apparatus for securing asuture at a location within a confined space, wherein the apparatuscomprises: a cartridge, wherein the cartridge further comprises: acartridge body member having an attachment point; and a first needle anda second needle attached to opposite ends of a length of suture materialmounted on the cartridge body member; and an applicator tool, whereinthe applicator tool further comprises: an applicator tool body memberwhich defines an internal cavity, the applicator tool body memberincluding an attachment point which joins with the cartridge body memberattachment point; and a needle deployment mechanism contained within theapplicator tool body member internal cavity, the needle deploymentmechanism holding the first and second needles and having a firstposition wherein the first and second needles are contained within thebody member internal cavity and a second position wherein the first andsecond needles are located outside of the body member internal cavity.In this embodiment, the needle deployment mechanism may further comprisefirst and second needle carriers for holding the first and secondneedles. Additionally, the first and second needle carriers may have asubstantially semi-circular shape.

The invention also includes a surgical needle comprising an elongatebody section with a substantially uniform cross sectional area having adistal end, a pointed proximate end and a shoulder located intermediatethe distal end and the pointed proximate end, the shoulder defined by anabrupt change in the cross sectional area of the body section, thetransition between the body section and the shoulder defining a planewhich is substantially perpendicular to a longitudinal axis of theelongate body section. In this embodiment, the elongate body section maytake on a variety of cross section shapes including but not limited toconical, rectangular, or triangular. The surgical needle of thisembodiment may further comprise a means for attaching a suture to thebody section distal end. Additionally, this means for attaching a sutureto the body section distal end may further comprise an eye formed in thebody section.

Yet another embodiment of the invention includes a suture cartridge foruse with a suture applicator, the suture cartridge comprising: a needle;a suture attached to the needle; and a support which holds the needleand suture in a predetermined configuration with respect to the support,the support further including a means for attaching the suture cartridgeto the suture applicator. Additionally, the suture cartridge may furthercomprise an alignment element which aligns the cartridge with the sutureapplicator in a predetermined configuration. In another variation, thesuture cartridge may further comprise a needle loader for loading theneedle into the suture applicator, the loader comprising a body memberhaving a needle pocket and a needle retainer which holds the needle inthe pocket, the loader body member further including an alignmentfeature which positions the needle in a predetermined configuration withrespect to the suture applicator.

The invention further includes a needle loading device for loading asurgical needle into a suturing tool, the loading device comprising abody member having a needle pocket and a needle retainer which holds theneedle in the pocket, the loading device body member further includingan alignment feature which positions the needle in a predeterminedconfiguration with respect to the suturing tool.

Another embodiment of the invention is a suturing apparatus comprising:a suture cartridge comprising: a needle; a suture attached to theneedle; and a support which holds the needle and suture in apredetermined configuration with respect to the support, the supportfurther including a tool attach fixture; and an applicator tool, whereinthe applicator tool further comprises: an applicator body member whichdefines an internal cavity, the applicator body member including anattachment fixture which, in combination with the cartridge support toolattach fixture, mounts the suture cartridge to the applicator tool; anda needle deployment mechanism contained within the applicator bodymember internal cavity, the mechanism having a first position whereinthe needle is contained within the body member internal cavity and asecond position wherein the needle is located outside of the body memberinternal cavity. This embodiment may further include a needle loadercomprising a body member having a needle pocket and a needle retainerwhich holds the needle in the pocket, the needle loader body memberfurther including an alignment feature which positions the needle in apredetermined configuration with respect to the needle deploymentmechanism.

Another embodiment of a suturing apparatus is characterized by a needlecomprising a point which is connected to a shoulder by means of atapered section wherein the connection of the tapered section to theshoulder defines a first cross sectional transverse dimension of theshoulder, the shoulder further connected to a distal portion of theneedle immediately adjacent the connection of the tapered section withthe shoulder, wherein the connection of the distal section to theshoulder defines a second cross sectional transverse dimension of theshoulder which is smaller than the first cross sectional transversedimension of the shoulder thereby forming a shoulder ledge; a sutureattached to the distal portion of the needle; and a needle catchcomprising a flexible aperture having a first relaxed dimension which issmaller than the first cross sectional transverse dimension of theshoulder but allows insertion of the needle into the aperture along aninsertion direction by expansion of the flexible aperture first relaxeddimension to a stretched dimension which is substantially equal to thefirst cross sectional transverse dimension of the shoulder by thepassage of the tapered section, the aperture returning to a secondrelaxed dimension, also smaller than the first cross sectionaltransverse dimension of the shoulder, the shoulder ledge therebypreventing removal of the needle from the catch in a direction which isthe reverse of the insertion direction. In this embodiment, the needlecatch may further comprise a removal aperture, contiguous with theflexible aperture, the removal aperture having a dimension which islarger than the first cross sectional transverse dimension of theshoulder, thereby allowing the needle to be removed from the needlecatch when the needle is moved from the flexible aperture to the removalaperture.

The invention also describes a passive needle catch for receiving andretaining a shouldered surgical needle, the catch comprising a flexibleaperture which expands to allow passage of the needle shoulder into theaperture and contracts after the needle shoulder has passed through theaperture. This passive needle catch may further comprise a removalaperture, contiguous with the flexible aperture, the removal aperturehaving a dimension which is larger than the needle shoulder, therebyallowing the needle to be removed from the needle catch when the needleis moved from the flexible aperture to the removal aperture.

The invention further includes a passive needle catch for a shoulderedsurgical needle, the catch comprising an aperture having a first regionwhich has a dimension which is at least as large as the needle shoulderthereby allowing passage of the shoulder through the aperture, the catchfurther having a second region which has a dimension which is smallerthan the needle shoulder, thereby preventing passage of the shoulderthrough the aperture.

These and other characteristics of the present invention will becomeapparent through reference to the following detailed description of thepreferred embodiments and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and advantages of the subject invention willbecome more fully apparent from a reading of the following descriptionin conjunction with the drawings wherein:

FIGS. 1A through 1H illustrate the general structure and operation ofthe present invention.

FIG. 2 is a cross sectional plan view showing a single needle guideinside a cannula.

FIG. 3 is a cross sectional plan view showing the needle guide in thedeployed position.

FIG. 4A is a detailed perspective view showing that there are two needleguides.

FIG. 4B is a detailed perspective view showing only one of the needleguides in the deployed position.

FIG. 5 is a detailed perspective view of the top section of the deviceshowing the deployment catch mechanism.

FIG. 6 is a detailed plan view of a swinging needle guide positioned inthe cannula and a phantom view showing the needle guide in the deployedposition.

FIG. 7 is an exploded perspective view of the major components of thepresent invention.

FIG. 8 is a cross sectional side view of the abdomen with a trocarinserted, showing the wound in the abdominal wall.

FIG. 9 is a cross sectional side view of the present invention in placein the abdomen.

FIG. 10 is a detail cross sectional side view of the present inventionin place in the abdomen with the needle guides deployed.

FIG. 11 is a detail plan view similar to view 6 showing a needle in aguide with the guide deployed.

FIG. 12 is a detail plan view similar to view 6 showing a flexiblemember being pushed into the guide.

FIG. 13 is a detail plan view similar to view 6 showing a needle beingpushed into a catch.

FIG. 14 is a detail plan view similar to view 6 showing the needlecarrier being retracted, the needle secured in the catch and trailing asuture.

FIG. 15 is a detail plan view similar to view 6 showing the needle guideretracted back into the housing.

FIG. 16 is a detail plan view similar to view 6 showing the suture leftin place in the wound before tying.

FIG. 17 is a detail plan view of an elongate needle guide design withthe guides contained within a cannula.

FIG. 17A is an enlargement of the end of the embodiment shown in FIG.17.

FIG. 18 is a detail plan view of the elongate needle guide design withthe guides in the deployed position.

FIG. 18A is an enlargement of the end of the embodiment shown in FIG.18.

FIG. 19 is a detail perspective view of a needle showing ridges on theneedle to secure the needle in the catch.

FIG. 19A is a detail plan view of an alternate needle.

FIG. 19B is a detail plan view of another alternate needle.

FIG. 19C is a detail perspective view of an alternate catch mechanismwith a needle.

FIG. 19D is a detail perspective view of another catch mechanism with aneedle.

FIG. 20 is a detail plan view of the semicircular needle holder withouta needle guide with the holder positioned within the cannula.

FIG. 20A is a detail sectional view of the needle holder and needleassembly.

FIG. 21 is a detail plan view of the semicircular needle holder beingdeployed.

FIG. 22 is a detail plan view of the semicircular needle holder pushingthe needle into the catch.

FIG. 23 is a detail plan view of the semicircular needle holder with theholder being retracted.

FIG. 24 is a exploded perspective view of an alternate embodiment of thepresent invention which allows each of the guide tracks to be actuatedindependently.

FIGS. 24A through 24D illustrate the general operation of theindependent guide deployment.

FIG. 25 is an exploded perspective view of the general structure of asuture loading system.

FIG. 26 is a perspective view of the assembly described in FIG. 25

FIG. 27 is a detail cross sectional plan view of an alternate embodimentof a suture loading system.

FIGS. 28A through 28C are detail cross sectional plan views whichillustrate the insertion of the needle into the needle carrier.

FIG. 29 is a detail cross sectional plan view of an alternate embodimentof a suture loading system.

FIGS. 30A through 30C are detail cross sectional plan views of analternate embodiment which illustrate the insertion of the needles intothe needle carriers.

FIG. 31 is a detail perspective view of an alternate embodiment of thepresent invention for a suture application device which includes acannular body and a keyhole shape needle catch.

FIGS. 32A through 32C show sectional detail plan views of a suturedevice interlock assembly in its initial, first stage of deployment andsecond stage of deployment configurations, respectively.

FIG. 33 shows a detail perspective view of a lockout pawl in theinterlock assembly.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Although the principles of the present invention are applicable to anydevice suitable for use in surgical procedures, whether performed onhumans or animals, particular utility is effected in human abdominalsurgery performed using endoscopic techniques for closure of the woundscreated during the introduction of trocars into the abdominal cavity,and particularly the puncture wounds created thereof, as well as closureor approximation of the wounds created either during the resection ofbenign or malignant lesions, or during the performance of othertherapeutic procedures on an organ or organs within a body cavity.

FIGS. 1A through 1H illustrate the general structure and operation ofthe present invention. FIGS. 1A and 1B show a device 2, according to thepresent invention, which incorporates a length of standard suturematerial 4 with a needle 6 on each end. The needles 6 are held by aneedle carrier 8 (FIG. 1D) and loaded into two guiding tracks 10. Theguiding tracks 10, containing the needle carriers 8 and needles 6, aredeployable outside a housing 12 of the device 2 to allow the suturematerial 4 to be placed outside the limits of a puncture wound 14 (FIGS.1B and 1C). After deployment of the guiding tracks 10 (with the needlecarriers 8 and needles 6 contained within) the needle carriers 8 andneedles 6 are driven out of the guiding tracks 10 and into tissuesurrounding the puncture wound 14 (FIGS. 1C and 1D). The needles 6 aredriven into a catch mechanism 16 (FIG. 1D). The needle carriers 8 areretracted back into the guiding tracks 10 (FIG. 1E). The guiding tracks10 (now containing only the needle carriers 8 without the needles 6) andthe catch mechanism 16 with the captured needles 6, are retracted asshown in FIGS. 1F, 1G and 1H. With a loop of suture 4 having thus beenplaced in the tissue surrounding the puncture wound 14, the suturedevice 2 is removed from the wound 14, thereby pulling the ends of thesuture 4 with it (FIG. 1H). Closure of the puncture wound 14 isaccomplished by cutting the suture 4 to remove the needles 6, tying aknot in the suture 4, and pushing it into the wound 14. Superficialclosure is then performed by normal means according to the surgeon'spreference.

Detailed drawings of an illustrative embodiment of the invention areshown in FIGS. 2, 3, 4A, 4B, 5, 6 and 7 wherein a suture applicationdevice 30 includes an outer housing 32, with finger grips 34a and 34b,and a deployment catch 36. The outer housing 32 is preferably made ofinjection molded plastic such as polycarbonate, as are many other of thecomponents described herein. A deployment sleeve 38, slidably disposedwithin the outer housing 32, has a retention catch 40 and is attached toa pushrod 42, constructed for example, of stainless steel. A drivershaft 44 includes a button 46 and has a hole 48a, into which is bondedan elongate rigid shaft 50a. The rigid shaft 50a, which may be made ofmusic wire, passes through outer housing ribs 52a, 52b and 52c, and asbest shown in FIG. 4A, terminates slidably disposed within a hollowcylinder 54a. The hollow cylinders 54a and 54b, preferably made fromstainless hypodermic tubing, are held in recesses in the outer housingribs 52b and 52c. An elongate flexible tubular member 56a, that may bemade of polypropylene or other suitable material, is also slidablydisposed within the hollow cylinder 54a. As shown in FIG. 6, needleguide 58a may also be constructed from stainless hypodermic tubing, andhas pivot pins 60a and 60b pivotally disposed within outer housingbosses 62a and 62b. A driving link 64a is attached by a link pin 66 tothe pushrod 42 and to the needle guide. 58a by a pivot pin 68a, with theentire mechanism preferably made of stainless steel so as to maximizethe biocompatibility as well as the strength of the actuating members.It may be appreciated from FIG. 4A that, as described, there are twoneedle guides 58a and 58b oppositionally disposed within the outerhousing 32.

Referring again to FIGS. 2 and 3, a driver retainer 70 is slidablydisposed within the outer housing 32, and is fixably attached to rigidshafts 50a and 50b, with a hole 72 to allow the pushrod 42 to passslidably therethrough. A driver spring 74, preferably wound fromstainless steel wire is compressed between the driver retainer 70 andthe outer housing rib 52b. A deployment spring 76, also made ofstainless steel wire is compressed between an end 77 of the deploymentsleeve 38 and outer housing rib 52a. A needle catch 78a is housed withina recess 80a in the outer housing 32.

Referring now to FIG. 6, a retraction line 82a that is preferably madeof kevlar, is slidably threaded through the flexible tubular member 56aand is attached to a needle carrier 84a by means of a crimp 86a or othermeans that would bind the retraction line 82a to the needle carrier 84a.The distal end of the retraction line 82a is attached to the rigid shaft50a by means of another crimp 98a or other means. The needle carrier 84ais slidably disposed within the needle guide 58a, and holds a needle88a, typically constructed of surgical grade stainless steel in a recess90a, such needle having a suture 92a attached thereto. The suturematerial is preferably polyglycolic acid, but may be made ofpolypropylene, nylon, silk, catgut, or any other materials known in theart selected for their biocompatibility and tensile strength to be usedin the body for the approximation of tissue. The suture 92a exits theneedle guide 58a by means of a groove 94a (groove 94a is hidden fromview in FIGS. 4A and 4B, however, groove 94b in the opposing needleguide 58b is visible), and is stored in a recess 96 in outer housing 32.

Referring to FIG. 7, it may be seen that outer housing 32 may comprisetwo halves, 32a and 32b which are joined by pins 100 and holes 102. Thepins 100 and holes 120 are preferably molded into the outer housinghalves 32a and 32b to encompass an inner assembly 104.

Use and operation of this embodiment of the invention will be describedbeginning with reference to FIG. 8 which shows a trocar assembly 106inserted into the abdominal wall 108, which includes a layer of skin110, a fat layer 112, a muscle layer 114 and a fascial layer 116. Thetrocar assembly 106 includes a hollow tube 118 that is inserted throughthe abdominal wall 108 and into an abdominal cavity 122 using techniqueswell known to those skilled in the art, creating a puncture wound 120.As shown in FIG. 9, the suture application device 30 of the presentinvention is inserted through the hollow tube 118 into the trocarassembly 106 until it passes into the abdominal cavity 122. Referring toFIG. 3, arm 124 of deployment sleeve 38 is pushed so that the sleeveslides within the outer housing 32, compressing spring 76, and in turnsliding pushrod 42. As can be seen in FIGS. 4A and 4B, when the pushrod42 slides relative to the outer housing 32, driving links 64, which arepivotally attached to both pushrod 42 and needle guides 58, force theneedle guides 58 to pivot about the pins 60 that are retained in outerhousing bosses 62. The ultimate deployed position of one of the needleguides 58a is shown in perspective view in FIG. 4B and in crosssectional plan view in place in the body in FIG. 10. Referring to FIG.10, it can be seen that the suture device 30 is in place through thehollow tube 118 and in the abdominal cavity 122, with needle guides 58deployed and engaging the fascial layer 116 and the muscle layer 114.

Operation of the needle driver portion of this embodiment will bedescribed by referring to FIGS. 11 through 15. It should be understoodthat in the interest of clarity only one half of the instrument is beingshown. In FIG. 11, the needle guide 58a has been deployed by movement ofthe pushrod 42 attached to the deployment link 64a. As shown in FIG. 12and FIG. 13, the rigid shaft 50a within the hollow cylinder 54a isslidably moved and in turn pushes the flexible tubular member 56a,thereby displacing the needle carrier 84a along an arc described by theneedle carrier 58a. The needle carrier 58a pushes the needle 88acarrying the suture 92a through the tissue and into the catch 78a asbest shown in FIG. 13. The needle catches 78 are preferably made of thingauge surgical grade stainless steel which allows the leaves to beflexible yet create a gripping force on the needles 88. Referring toFIG. 14, the rigid shaft 50a is retracted, and because of the retractionline 82a, the needle carrier 82a is retracted back into needle guide 58aand the flexible tubular member 56a is retracted back into the hollowcylinder 54a. As shown in FIG. 15, the pushrod 42 is retracted, by whichthe linkage previously described rotates the needle guide 58a back intothe outer housing 32. Referring to FIG. 16, the suture applicationdevice 30 and the trocar assembly 106 are completely withdrawn from theabdominal wall 108, leaving the suture 92 in the abdominal wall 108, tobe tied, completing the approximation of the wound 120.

Another embodiment of the described invention is shown in FIGS. 17, 17A,18 and 18A. It should be understood that in the interest of clarity onlyone half of the instrument is being shown. The second half is a virtualcopy of the first half in both function and structure. Typical materialsused in this embodiment are injection molded materials such aspolycarbonate, and surgical grade stainless steel.

A suture application device 126 includes an outer housing 128, withfinger grips 130a and 130b, and a deployment catch 132. A deploymentsleeve 134, slidably disposed within the outer housing 128, has aretention catch 136. A driver shaft 138, which is slidably disposedwithin the deployment sleeve 134 includes a button 140 and has a hole142, into which is bonded an elongate rigid shaft 144. The rigid shaft144 passes through a hole 146 in the deployment sleeve 134, through ahole 148 in an outer housing rib 150, through another hole 152 in thedeployment sleeve 134 and terminates slidably disposed within a hollowcylinder 154. The hollow cylinder 154 is pivotally attached to thedeployment sleeve 134 by means of a pivot pin 156 disposed on eitherside of the hollow cylinder 154, and inserted into holes 158 indeployment sleeve 134. An elongate flexible member 160 is also slidablydisposed within the hollow cylinder 154. A needle guide assembly 162includes: a needle guide 164, secured within the hollow cylinder 154 soas to allow the flexible member 160 to slidably transition from thehollow cylinder 154 to the curved needle guide 164; a needle 166 towhich is secured a suture 168; and a needle catch 174 secured between aboss 170 and another boss 172.

Use and operation of this embodiment of the invention will be describedbeginning with reference to FIG. 18. The suture application device 126is introduced into the abdomen through a trocar assembly in the samemanner as described in the previous embodiment. Subsequently, adeployment arm 177 is pushed such that the retention catch 136 snapspast the deployment catch 132. Deployment sleeve 134 slides within theouter housing 128 and compresses deployment spring 176 between a wall178 of the deployment sleeve 134 and the outer housing rib 150. Theneedle guide assembly 162 is forced to slide along with the deploymentsleeve 134 with a cam 182 riding in a track 184, deploying the needleguide assembly as shown in FIGS. 17, 17A, 18, and 18A. Similar to thepreviously described embodiment, the needle 166 is driven out of theneedle guide 164 by pushing the button 140, thereby pushing the rigidshaft 144, which in turn pushes the flexible member 160, which followsthe curvature of needle guide 164 and pushes the needle into the catch174. As seen in FIG. 18, the length of travel permitted button 140 isrestricted by a slot 194 in driver shaft 138 sliding past a pin 192secured to the deployment sleeve 134.

The needle guide assembly 162 is retracted back into the outer housing128 by releasing the catch 132. The spring 176 forces the deploymentsleeve 134 back to its original position, thereby causing the cam 182 tofollow the track 184 such that the position of the needle guide assembly162 is once again as shown in FIGS. 17 and 17A.

FIG. 19 shows a detail view of the needle 166 secured to the suture 168as it enters the catch 174 through a slot 186 created by spring leaves188a and 188b. The catch 174 is preferably made of thin gauge springsteel to allow the leaves to be flexible yet create a gripping force onthe needle. Ridges 190 on needle 166 enable the catch 174 to capture andhold the needle 166. The capture and holding of the needle 166 by thecatch 174 is facilitated by the spring leaves 188 being disposed to bendaway from the axis of needle penetration, thus snapping into the ridges190.

FIGS. 19A through 19B show detail plan views of alternate needleembodiments. Referring to FIG. 19A, a needle 234 comprises a body 236,and a shoulder 238 tapering to a point 240. A length of suture material242 is inserted into a hole 244 and attached to the needle 234 thereby.Referring now to FIG. 19B, a needle 246 comprises a body 248 and ashoulder 250 formed by a groove 252 which tapers to a point 254. Alength of suture material 256 is inserted into a hole 258 and attachedto the needle 246 thereby.

FIGS. 19C through 19D show detail perspective views of alternate catchembodiments and illustrate their operation. A catch 260 is preferablyconstructed of thin stainless steel of high temper, such as ANSI 301full hard. Referring to FIG. 19C, a catch 260 includes openings 262defined by ribs 264. As the needle 234 enters the opening 262, the ribs264 deflect slightly to allow the shoulder 238 to pass through. Afterthe shoulder 238 has passed the ribs 264, the ribs spring back to theiroriginal position defining the openings 262. The openings 262 are chosento be smaller in dimension than the shoulder 238. This causes the catch260 to retain the needle 234 by the interference between the shoulder238 and the ribs 264 around the body 236. When it is necessary to removethe needle 234 from the catch 260, it may be moved toward an opening 265which is sized to allow the needle shoulder 238 to pass through withoutresistance.

Referring now to FIG. 19D, a catch includes a frame 268 to which isattached a woven mesh 270. Threads 272 creating the woven mesh 270 maybe made out of nylon or polyester or the like woven in a commonover/under pattern. The weaving of the threads 272 creates holes 274 inthe mesh through which a needle 246 may be passed. The needle 246 isconstructed such that the shoulder 250 defined by the groove 252 islarger than the holes 274, or conversely, the holes 274 are chosen to besmaller than the shoulder 250. The point 254 of the needle 246 pushesthe threads 272 aside creating room for the shoulder 250 to pass throughthe holes 274. As the threads 272 return to their original positions,the catch 266 holds onto the needle 246 by means of the mismatch in thesize of the holes 274 and the shoulder 250.

It may be seen and should be understood that catches 260 and 266 arecapable of catching either needle 234 or 246. The examples of needle 234coupled with catch 260 and needle 246 coupled with catch 246 are givenpurely to illustrate the concepts of each embodiment and do not excludetheir coupling with alternate designs.

Yet another embodiment of the present invention is shown in FIGS. 20,20A, 21, 22 and 23. It should be again understood that in the interestof clarity only one half of the instrument is being shown. The otherhalf is quite similar in function and structure as the half describedherein. The upper portion of the device is similar in construction andmaterials to the previously disclosed embodiments, and is not repeatedhere.

A suture application device 196 includes an outer housing 198 havingbosses 200 into which a pin 202 is rotatably inserted. The pin 202 issecured to an arm 204, which is attached to a needle carrier 206. A pin208 on needle carrier 206 is rotatably inserted into a hole 210 in alink 212. Another pin 214 is secured to a pushrod 216 and is rotatablyinserted into another hole 218 in the link 212. The pushrod 216 isattached to a sleeve 220 slidably disposed within the outer housing 198.

FIG. 20A shows a detail view of a needle 222 held in a recess 224 in theneedle carrier 206. A suture 226 is attached to the needle 222 and isthreaded through a slot 228 in the needle carrier 206. All components inthis mechanism are preferably constructed of surgical grade stainlesssteel, chosen for its biocompatibility and strength.

Use and operation of this embodiment of the invention will be describedbeginning with reference to FIG. 20. The suture application device 196is introduced into the abdomen through a trocar assembly in the samemanner as described in a previous embodiment. Sleeve 220 slides withinthe housing 198 in the direction indicated by the arrow. As shown inFIG. 21, as the sleeve 220 moves, it pushes the pushrod 216 which causesthe link 212 to cause the needle carrier 206, along with the needle 222and the suture 226, to rotate about the axis defined by the pin 202.Referring to FIG. 22, it may be seen that the needle 222 is driven intoa catch 230 through an opening 232 in the outer housing 198.Accordingly, in reference to FIG. 23, it is seen that as the pushrod 216is retracted, the link 212 is also retracted, causing the needle carrier206 to rotate about the pivot pin 202 and back through the opening 232into the outer housing 198, the same position as shown in FIG. 20.

Another embodiment of the present invention is described in FIGS. 24,24A, 24B, 24C, and 24D. FIG. 24, shows an exploded perspective view of asuture device which is similar in construction to the previouslydescribed suture application device 30 and includes an outer housing 32,comprised of two halves 32a and 32b, with finger grips 34a and 34b, anda deployment catch 36. Residing within the outer housing 32, areindependent needle driver assemblies 278a and 278b. For purposes ofdiscussion, only one of the needle driver assemblies 278 will bedescribed, although it should be understood that both are substantiallyidentical in structure and function.

A deployment sleeve 280a, slidably disposed within the outer housing 32,has a retention catch 282a and is attached to a pushrod 284a,constructed for example, of stainless steel. A driver shaft 286aincludes a button 288a and has a hole 290a, into which is bonded anelongate rigid shaft 50a. The rigid shaft 50a, which may be made ofmusic wire, passes through outer housing ribs 52a, 52b and 52c. Inconstruction similar to and as best shown in FIG. 4A, the rigid shaft50a terminates slidably disposed within the hollow cylinder 54a, whichis held in recesses in the outer housing ribs 52b and 52c. Elongateflexible tubular member 56a, that may be made of polypropylene or othersuitable material, is also slidably disposed within the hollow cylinder54a. As shown in FIG. 6, needle guide 58a may also be constructed fromstainless hypodermic tubing, and has pivot pins 60a and 60b pivotallydisposed within outer housing bosses 62a and 62b. A driving link 64a isattached by a link pin 66 to the pushrod 42 (284a in FIG. 24) and to theneedle guide 58a by a pivot pin 68a, with the entire mechanismpreferably made of stainless steel so as to maximize thebiocompatibility as well as the strength of the actuating members. Itmay be appreciated from FIG. 24 that, as described, there are two needleguides 58a and 58b oppositionally disposed within the outer housing 32.

Referring again to FIG. 24, driver retainer 70 is slidably disposedwithin the outer housing 32, and is fixably attached to rigid shafts 50aand 50b, with a hole 72 to allow the pushrod 284a to pass slidablytherethrough. Driver spring 74, preferably wound from stainless steelwire is compressed between the driver retainer 70 and the outer housingrib 52b.

It may be appreciated by the foregoing that the needle driver assemblies278a and 278b may be actuated independently. The internal mechanisms andcomponents are similar in construction to the embodiment described inFIG. 1A through 1H.

FIGS. 24A through 24D illustrate the use and operation of thisembodiment of the invention. The use of this embodiment will bedescribed beginning with reference to FIG. 24A which shows a suturedevice 276 inserted through the abdominal wall 108, which includes alayer of skin 110, a fat layer 112, a muscle layer 114 and a fasciallayer 116. Within the abdominal cavity 122 lies a hollow organ 292,which may be, for example, a uterus. The organ includes walls 294 intowhich an opening 296 has been made. The opening 296 would generally havebeen created by a surgeon using traditional surgical tools such as ascalpel or scissors, and may have been made in order to excise a fibroidtumor or the like. The suture device 276 is inserted into the opening296. Referring to FIG. 24B, the deployment sleeve 280a is depressed,rotating the needle guide 58a outside the bounds of the housing 32. Thedeployment sleeve 280a is locked down by deployment catch 282a. Theneedle 88a is attached to the suture material 92, and rests in therecess 90a in the needle carrier 84a (also see FIG. 6 for a moredetailed view). Needle driver button 288a is depressed, driving theneedle carrier 84a holding the needle 88a through the organ wall 294aand into the needle catch 78a. The needle driver button 288a is returnedto its original position, and the deployment sleeve 280a retracted,leaving the suture 92 placed through one wall 294a of the hollow organ292 utilizing needle driver assembly 278a. FIG. 24C illustrates asimilar process on the opposing wall 294b of the hollow organ 292utilizing needle driver assembly 278b. Referring to FIG. 24D, it can beseen that the suture 92 is withdrawn through the abdominal wall wherethe suture 92 is cut away from the suture device 276. A knot is thentied in the suture 92 to approximate the walls 294 of the hollow organ292, and additional sutures 92 are placed as necessary.

Other embodiments of the present invention comprise modifications of theabove embodiments which include a single needle driver, either with orwithout a catch system. The single needle driver embodiments perform thesame function as the dual needle driver embodiments described herein,with minor operational modifications. For example, the single needledriver embodiments require that the suture application device be removedfrom the body cavity to load the second needle. In some applications,however, this is not a severe operational limitation, and single sidedneedle drivers or suturing devices should be understood to becontemplated in addition to the above described dual needle embodiments.

In some applications, such as for the placement of sutures forsuspension of the bladder for the treatment of female incontinence, itmay be desirable to use a single sided device. This is due to thelimited space for deployment and visualization of the instrument. Forbladder suspension, the device may be used as follows. After loading asemi-circular needle similar to that shown in FIG. 19B into a singleguiding track, the suture application device is introduced into the bodycavity via a surgical trocar, and a suture is driven into the vaginalwall just below the urinary bladder neck. The suture application deviceis manipulated to catch the needle, and the device withdrawn from thebody cavity carrying the needle and suture. The opposite end of thesuture, which also has an attached needle, is then loaded into thesuture application device, and introduced back into the body cavity.This needle is driven through one side of Cooper's ligament, and againthe device withdrawn from the body. The surgeon may then repeat the samesequence, driving through the opposite side of Cooper's ligament. Thesurgeon may then tie the sutures at his discretion, placing the properamount of tension on the sutures to effect the suspension of thebladder.

A similar sequence may be contemplated for use in other applicationssuch as the previously mentioned closure of a body organ, or of thefascial puncture wounds. It may also be contemplated for use in theplacement of gastrostomy tubes, or in the approximation of tissue flapssuch as that accomplished in gastric fundoplication.

Referring now to FIG. 25, there may be seen the tip of a sutureapplication device 304 which includes a cannular body 306, a hinged tip308 and a suture carrier plate 310. The suture carrier plate 310 may bemolded from polyethylene or other suitable material which may be adaptedfor the "bone dry" sterilization process previously described. A pieceof suture material 312 has needles 314a and 314b, which as before arepreferably constructed from surgical grade stainless steel, attached toeach end 316 to form a suture 318. The suture 318 is wound to fit overpegs 320 on the suture plate 310. Tabs 322 are molded into the plate 310and are constructed to fit into recesses 324 molded or otherwise placedin the walls of the cannular body 306. Hollow posts 326 formed in thecannular body 306 are sized appropriately to fit snugly into holes 328,and post 330 is concomitantly sized to fit into hole 332 and along withthe tabs 322 and the recesses 324, provide guidance and retention of theplate 310 within the cannular body 306. As may be seen by referring toFIGS. 25 and 26, when the hinged tip 308 is pivoted about a hinge 334,projections 336 are made to fit into recesses 338 in the cannular body306 simultaneously causing posts 340 to mate with the hollow posts 326.The suture material 312 is guided in channels 342 on each side of thecannular body 306, and the needles 314 are loaded within the needleguides 58.

An example of an embodiment of a needle loading system is shown in FIG.27 and includes a cannular body 344 and a needle loader 346. The needleloader 346 includes two arms 348a and 348b which terminate in needlerecesses 350a and 350b, respectively, and are commonly attached tocrossbar 352. FIGS. 28A through 28C are detail cross section plan viewswhich illustrate and describe the operation of the needle loader. As maybe seen in FIG. 28A, the needle recess 350 attached to the arm 348contains a needle 354 to which is attached a piece of suture material356. The needle 354 is held within the recess 350 by fingers 358. Thefingers 358 are bent inward such that a deflective force causes them tohold the needle by shank 360, butting up against shoulder 362. Referringnow to FIG. 28B, it may be seen that as the needle recess 350 is movedin the direction indicated by the arrows, the fingers 358 are deflectedeven further by needle guide 364 causing the fingers 358 to release theneedle shank 360 and clear the needle shoulder 362. This movement forcesthe needle shank 360 to slide into slot 366 in needle carrier 368, asbest shown in FIG. 28C. Referring back to FIG. 27, it may be seen thatthe force indicated by the arrows in FIGS. 28A and 28B may be providedby a thumb 370 and finger 372. It may be clearly seen that the suturecarrier plate 310 may be loaded into the cannular body 344 as previouslydescribed in reference to FIGS. 25 and 26.

An alternate embodiment of the needle loading system is shown in FIG. 29wherein a needle loader 374 includes arms 376a and 376b and needlerecesses 378a and 378b. As may be clearly seen, the needle recesses 378are similar in construction and operation to those described in FIGS.28A through 28C. However, in this embodiment, the needle loader 374 isconstrained to glide along cannular body 380, aligning recesses 378 withneedle guides 382, and subsequently loading needles 384 as previouslyoutlined. As before, it may be clearly seen that the suture carrierplate 310 may be loaded into the cannular body 380 as previouslydescribed in FIG. 25 and FIG. 26.

FIGS. 30A through 30C are detail section views which describe yetanother embodiment of a needle loading system 386 which includes acartridge 388 and a needle loader 390. The cartridge 388 is preferablymolded out of polycarbonate or the like, and includes a flange 392 onwhich are projections 394 which are sized and designed to fit intorecesses 396 in the cannular body 398. The needle loader 386 which ispreferably molded out of a malleable plastic such as polypropylene,includes arms 400a and 400b and needle recesses 402a and 402b. As may beclearly seen, the needle recesses 402 are similar in construction andoperation to those described in FIGS. 28A through 28C. In thisembodiment, and as shown in FIG. 30B, the needle loader 386 isconstrained to be engaged with the cartridge 388. As the flange 392 issnapped into the cannular body 398, projections 394 are engaged intorecesses 396, aligning the needle recesses 402a and 402b with needleguides 404a and 404b, respectively. Referring now to FIGS. 30B and 30C,it may be clearly seen that by squeezing the needle recesses 402 anddeflecting arms 400, the needles 406 are loaded into openings 408 in theneedle guides 404 and subsequently into needle carriers 410 aspreviously outlined in FIGS. 28A through 28C. FIG. 30C shows that theneedle loader 386 has been removed from the cartridge 388 leaving theneedles 406 loaded and ready for use.

Referring now to FIG. 31, there may be seen a detail perspective view ofa suture application device 412 which includes a cannular body 414 and aneedle catch 416. The needle catch 416 includes slots 418 and openings420. Needle 422 includes a point 424 and a shoulder 426. The needlecatch 416 is designed such that the openings 420 are large enough forthe point 424 and the shoulder 426 of the needle 422 may easily passthrough. After the needle 422 has been driven into tissue, the sutureapplication device 412 may be manipulated to allow the point 424 and theshoulder 426 of the needle 422 to enter the opening 420. The sutureapplication device 412 may then be moved to allow the shoulder 426 toslide down in the slot 418 which is sized such that the shoulder 426 maynot pass through. Thus the needle 422 may be captured selectively at thediscretion of the user.

It may also be desirable to have an interlock assembly to prevent theuser of these devices from improper sequencing of the controls. It isnecessary for the needle guides previously described to be deployedprior to the needle driver control being activated. Improper sequencingmay cause a malfunction of the device. We therefore now describe aninterlock system which prevents improper control sequencing.

Referring to FIG. 32A, a sectional detail plan view of a suture deviceinterlock assembly 430 which includes a needle driver button 432attached to a shaft 434 which is slidably disposed within a guidedeployment sleeve 436. The guide deployment sleeve 436 includes a button438 and a hollow shaft 440 with keyhole slot 442 and is slidablydisposed within outer housing 444. Residing on the inside diameter ofhollow shaft 440 is a housing 446 dimensioned to allow the shaft 434 tomove slidably within it's inside diameter. At the end of the shaft 434is a recess 448 in which sits a bent wire 450. The housing 446 isultimately attached to the previously described pushrod 42 (see FIG. 6),and the bent wire 450 is attached to the previously described flexiblemembers 56a, 56b (FIG. 6). The outer housing 444 contains a pocket 452in which is slidably disposed a lockout pawl 454 which is forced byspring 456 to ride up into notch 458 in the shaft 434.

Referring now to FIG. 33, which is a detail perspective view of thelockout pawl 454 and the hollow shaft 440, it may be seen that thelockout pawl 454 has a head 460 which has a dimension larger than asmaller slot section 462 of the keyhole slot 442. This dimensionaldifference restrains the head 460 from passing down through the smallerslot section 462, thereby preventing the needle driver button 432 frombeing depressed.

Moving to FIG. 32B, it may be seen that as the button 438 is depressed,the keyhole slot 442 moves relative to the lockout pawl 454. Aspreviously described in other embodiments, this movement of button 438deploys the needle guides. Referring back to FIG. 33, it may be seenthat the larger slot section 464 of the keyhole slot 442 is moved into aposition which aligns the lockout pawl 454 with the larger slot section464. As may be seen in FIG. 32C, as the needle driver button 432 isdepressed, the lockout pawl 454 is driven back into the pocket 452against the tension of the spring 456 as the notch 458 in the shaft 434moves away from the lockout pawl 454. As previously described in otherembodiments, this movement of needle driver button 432 drives the needleor needles through tissue. It should be noted that as the lockout pawl454 drops into the larger slot section 464, it effectively prevents themovement of the hollow shaft 440. This has the effect of locking theneedle guides in the deployed position during the driving of theneedles. It also should be understood that the reverse movements of thecontrols will return the buttons to their original positions asdescribed in FIG. 32A.

It will be understood that the apparatus and method of the presentinvention for an endoscopic suture system may be employed in numerousspecific embodiments in addition to those described herein. Thus, thesenumerous other embodiments of the invention, which will be obvious toone skilled in the art, including but not limited to changes in thedimensions of the device, the type of materials employed, the locationand type of needles, driving mechanisms, catching mechanisms, needleloading mechanisms, etc., are to be included within the scope of thepresent invention. The apparatus and method of the present invention maybe embodied in other specific forms without departing from its spirit oressential characteristics. The described embodiments are to beconsidered in all respects only as illustrative and not restrictive. Thescope of the invention is, therefore, indicated by the appended claimsrather than by the foregoing description. All changes which come withinthe meaning and range of equivalency of the claims are to be embracedwithin their scope.

We claim:
 1. A suture device comprising:an elongate cannular body memberhaving a longitudinal axis and an internal chamber with a first lateralexit port near a distal end of said elongate cannular body member; afirst actuator located near a proximal end of said elongate cannularbody member and extending into said internal chamber, said firstactuator having a retracted position and a deployed position; and afirst needle deployment mechanism comprising a first needle carrierpivotally mounted within said internal chamber near said distal end ofsaid elongate cannular body member, said first needle deploymentmechanism connected to said first actuator and having a retractedconfiguration when said first actuator is in said retracted positionwherein substantially all of said first needle deployment mechanism iscontained within said internal chamber and a deployed configuration whensaid first actuator is in said deployed position, said first needledeployment mechanism includes means for transporting said first needlecarrier outside of said internal chamber through said first lateral exitport along a path having an initial direction away from said elongatecannular body member longitudinal axis as said first actuator begins tomove from said retracted position toward said deployed position followedby a direction toward said elongate cannular body member longitudinalaxis as said first actuator approaches said deployed position.
 2. Asuture device as defined in claim 1 further comprising:a needle having asuture attachment point inserted in said first needle carrier; a sutureattached to said needle suture attachment point; and a needle capturesystem located on said elongate cannular body member at a location whichintercepts said portion of said first needle carrier path whichapproaches toward said elongate cannular body member.
 3. A suture deviceas defined in claim 1 further comprising:a second actuator located nearsaid proximal end of said elongate cannular body member and extendinginto said internal chamber, said second actuator having a retractedposition and a deployed position; and a second needle deploymentmechanism comprising a second needle carrier pivotally mounted withinsaid internal chamber near said distal end of said elongate cannularbody member, said second needle deployment mechanism connected to saidsecond actuator and having a retracted configuration when said secondactuator is in said retracted position wherein substantially all of saidsecond needle deployment mechanism is contained within said internalchamber and a deployed configuration when said second actuator is insaid deployed position, said second needle deployment mechanism includesmeans for transporting said second needle carrier outside of saidinternal chamber through a second lateral exit port along a path havingan initial direction away from said elongate cannular body memberlongitudinal axis as said second actuator begins to move from saidretracted position toward said deployed position followed by a directiontoward said elongate cannular body member longitudinal axis as saidsecond actuator approaches said deployed position.
 4. A suture device asdefined in claim 3 further comprising a link which connects said firstactuator with said second actuator such that said second needledeployment mechanism is deployed simultaneously with said first needledeployment mechanism by either one of said first actuator or said secondactuator, wherein said first and second needle deployment mechanisms aredeployed on opposite sides of said elongate cannular body member.
 5. Asuture device as defined in claim 3 wherein said first actuatorcomprises a first sub-actuator and a second sub-actuator, each having aretracted position and a deployed position which is independent of theother, said first needle deployment mechanism includes means fortransporting said first needle carrier outside of said internal chamberalong said path having an initial direction away from said elongatecannular body member as said first sub-actuator moves from saidretracted position toward said deployed position followed by saiddirection toward said elongate cannular body member as said secondsub-actuator moves from said retracted position toward said deployedposition.
 6. A suture device comprising:an elongate cannular body memberwhich defines an internal chamber; a first actuator located near aproximal end of said elongate cannular body member and extending intosaid internal chamber, said first actuator having a retracted positionand a deployed position; a first needle deployment mechanism comprisinga first needle carrier pivotally mounted within said internal chambernear a distal end of said elongate cannular body member, said firstneedle deployment mechanism connected to said first actuator and havinga retracted configuration when said first actuator is in said retractedposition wherein substantially all of said first needle deploymentmechanism is contained within said internal chamber and a deployedconfiguration when said first actuator is in said deployed position,said first needle deployment mechanism includes means for transportingsaid first needle carrier outside of said internal chamber along a pathhaving an initial direction away from said elongate cannular body memberas said first actuator begins to move from said retracted positiontoward said deployed position followed by a direction toward saidelongate cannular body member as said first actuator approaches saiddeployed position; a second actuator located near said proximal end ofsaid elongate cannular body member and extending into said internalchamber, said second actuator having a retracted position and a deployedposition; and a second needle deployment mechanism comprising a secondneedle carrier pivotally mounted within said internal chamber near saiddistal end of said elongate cannular body member, said second needledeployment mechanism connected to said second actuator and having aretracted configuration when said second actuator is in said retractedposition wherein substantially all of said second needle deploymentmechanism is contained within said internal chamber and a deployedconfiguration when said second actuator is in said deployed position,said second needle deployment mechanism includes means for transportingsaid second needle carrier outside of said internal chamber along a pathhaving an initial direction away from said elongate cannular body memberas said second actuator begins to move from said retracted positiontoward said deployed position followed by a direction toward saidelongate cannular body member as said second actuator approaches saiddeployed position.
 7. A suture device as defined in claim 6 furthercomprising a link which connects said first actuator with said secondactuator such that said second needle deployment mechanism is deployedsimultaneously with said first needle deployment mechanism by either oneof said first actuator or said second actuator, wherein said first andsecond needle deployment mechanisms are deployed on opposite sides ofsaid elongate cannular body member.
 8. A suture device as defined inclaim 6 wherein said first actuator comprises a first sub-actuator and asecond sub-actuator, each having a retracted position and a deployedposition which is independent of the other, said first needle deploymentmechanism includes means for transporting said needle carrier outside ofsaid internal chamber along said path having an initial direction awayfrom said elongate cannular body member as said first sub-actuator movesfrom said retracted position toward said deployed position followed bysaid direction toward said elongate cannular body member as said secondsub-actuator moves from said retracted position toward said deployedposition.
 9. A suture device as defined in claim 6 further comprising:aneedle having a suture attachment point inserted in said first needlecarrier; a suture attached to said needle suture attachment point; and aneedle capture system located on said elongate cannular body member at alocation which intercepts said portion of said first needle carrier pathwhich approaches toward said elongate cannular body member.